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首页> 美国政府科技报告 >Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived Products
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Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived Products

机译：行业指南：核酸测试（NaT），以减少血浆衍生产品传播人类细小病毒B19的可能风险

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Food and Drug Administration (FDA) is issuing this guidance to provide manufacturers of plasma-derived products with recommendations for performing nucleic acid testing (NAT) for human parvovirus B19 as an in-process test for Source Plasma and recovered plasma used in the further manufacturing of plasma-derived products. Such testing will identify and help to prevent the use of plasma units containing high levels of parvovirus B19. This guidance also recommends how to report to FDA implementation of parvovirus B19 NAT. FDA recognizes that in the current business practice for parvovirus B19 NAT in-process testing, several weeks can elapse between collection of the units of Source Plasma or recovered plasma and identification of B19 NAT-positive pools or units. We encourage manufacturers of plasma-derived products to employ practices that will reduce the time between product collection and in-process testing to allow for the meaningful notification of blood and plasma collection establishments of positive test results within the dating period of any blood components intended for use in transfusion. This guidance finalizes the draft guidance of the same title, dated July 2008. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA's guidances means that something is suggested or recommended, but not required.

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